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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995 No. 360 URL: http://www.bailii.org/uk/legis/num_reg/1995/uksi_1995360_en.html |
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Statutory Instruments
FOOD
Made
15th February 1995
Laid before Parliament
17th February 1995
Coming into force
10th March 1995
The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(1) and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated(2) for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf; and after consultation in accordance with section 48(4) of the Food Safety Act 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said Act of 1990), hereby make the following Regulations:-
1.-(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995 and shall come into force on 10th March 1995.
(2) These Regulations shall not extend to Northern Ireland.
(3) In these Regulations "the principal Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1992(4).
2. The principal Regulations shall be amended as follows-
(a)in paragraph (4)(b)(i) of regulation 5, for the words "of not less than 500 millilitres and not more than 10 litres" there shall be substituted the words "of less than 500 millilitres or more than 10 litres";
(b)in paragraph (6) of regulation 5, for the words "regulation 3 comprising" there shall be substituted the words "these Regulations, where it is alleged that the commission of the offence is due to";
(c)in paragraph (2) of regulation 6, for the word "refences" there shall be substituted the word "references";
(d)before and above regulation 12 there shall be inserted the following heading to that regulation "Use, sale and importation until 1st April 1995";
(e)after regulation 12 there shall be inserted the following regulation-
13. Until 1st April 1996 a plastic material or article which has been manufactured using one or more of the monomers identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of Section D of Part I of Schedule 1-
(a)may be used in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption,
(b)may be sold for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption, or
(c)may be imported for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption,
provided that such monomer is of good technical quality and is used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof.";
(f)the Item number and letter, PM/REF No., CAS No., name and restriction (if any) for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 at the place corresponding to the number and letter specified for that monomer in the column headed `Item' in Schedule 1 to these Regulations;
(g)for the entry in column 4 (Restrictions) of Section A of Part 1 of Schedule 1, opposite and corresponding to item 26, there shall be substituted the following entry "The specific migration of this substance shall not exceed 5mg/kg.";
(h)the contents of Schedule 2 to these Regulations shall be substituted for Section B of Part 1 of Schedule 1;
(i)the contents of Schedule 3 to these Regulations shall be inserted after Section C of Part I of Schedule 1;
(j)after paragraph 4(2) of Section A of Part 1 of Schedule 2 there shall be inserted the following sub-paragraphs-
"(3) The verification of compliance with a migration limit using food shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use in accordance with the provisions of this Schedule.
(4) The verification of compliance with a migration limit using a simulant or simulants shall be carried out in accordance with the provisions of this Schedule using the simulant or simulants and the migration test conditions which are considered to be the most severe on the basis of experience.";
(k)in paragraph 1 of Part II of Schedule 2, in relation to Simulant D, after the words "sunflower oil.", there shall be inserted the following sentence "If rectified olive oil, a mixture of synthetic triglycerides or sunflower oil is not appropriate, other food simulants and conditions of time and temperature may be used.";
(l)for paragraph 1 of Part III of Schedule 2 there shall be substituted the following-
"1.-(1) Subject to paragraph (2) below, the migration testing of a plastic material or article which may come into contact with any food shall be carried out using one or more of the simulants specified in Part II of this Schedule.
(2) Simulant A shall not be used in migration testing of a plastic material or article which may come into contact with any food other than where its use is specified in the Table to Part IV of this Schedule.
(3) Subject to regulations 4(1) and 5(5), the migration testing of a plastic material or article which may come into contact only with a specific food or a specific group of foods shall be carried out-
(a)where the specific food or specific group of foods is specified in the Table to this part of this Schedule, using the simulant or simulants specified in relation to that specific food or specific group of foods; or
(b)where the specific food or specific group of foods is not specified in that Table, using the simulant or simulants which correspond most closely in extractive capacity to that food or group of foods.
(4) A simulant is specified in relation to a specific food or a specific group of foods for the purposes of this paragraph where `X' is placed in the column headed by that simulant opposite that specific food or specific group of foods in the Table to this Part of this Schedule, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part of this Schedule.
(5) Where more than one simulant is to be used in relation to a migration test, a new sample of the plastic material or article shall be used for each such test.";
(m)in paragraph 1 of Part IV of Schedule 2 for the words "paragraph 2" there shall be substituted the words "paragraphs 2 and 2A";
(n)in paragraph 1(a) of Part IV of Schedule 2 after the words "most closely to" there shall be inserted the words "but which are not less than";
(o)for sub-paragraphs (b) and (c) of paragraph 1 of Part IV of Schedule 2 there shall be substituted the following sub-paragraphs-
"(b)subject to sub-paragraph (d) below, where the intended use of a plastic material or article covers two or more combinations of time and temperature specified in column 1 of the Table to this Part of this Schedule, capability of migration shall be determined by subjecting that plastic material or article successively to each applicable test condition specified in column 2 using the same aliquot of simulant.
(c)subejct to sub-paragraph (d) below, where a plastic material or article is intended to be used under any conditions of time-
(i)if that plastic material or article may be used at any temperature not exceeding 70°C and such use is indicated by appropriate labelling or instructions, the 10 day test at 40°C shall be carried out;
(ii)if that plastic material or article may be used at a temperature exceeding 70°C and no labelling or instructions indicate the temperature expected in actual use, simulant D shall be used for 2 hours at 175°C and simulants B and C shall be used either-
(aa)at reflux temperature; or
(bb)for two hours at 100°C;
(iii)if that plastic material or article may be used at a temperature exceeding 70°C and labelling or instructions indicate conditions expected in actual use, times and temperatures shall be selected from the Table to this Part of this Schedule;";
(p)after sub-paragraph (c) of paragraph 1 of Part IV of Schedule 2 there shall be inserted the following sub-paragraph-
"(d)where a plastic material or article is intended to be used for periods of less than 15 minutes at temperatures of not less than 70°C and not more than 100°C and this is indicated by labelling or instructions, the 2 hour test at 70°C and the 10 day test at 40°C shall be carried out separately using a different sample of the plastic material or article for each test.";
(q)after paragraph 2 of Part IV of Schedule 2 there shall be inserted the following paragraph-
"2A. Migration testing of plastic materials and articles intended for use in a microwave oven shall be carried out using a conventional oven selecting appropriate time and temperature conditions from the Table to this Part of this Schedule.";
(r)the Table in Schedule 4 to these Regulations shall be substituted for the Table in Part IV of Schedule 2.
3. At the end of Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990(5) (provisions to which those Regulations do not apply) there shall be added in the left hand column the title to the principal Regulations and against it in the right hand column their reference.
Angela Browning
Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food
6th February 1995
Signed by the authority of the Secretary of State for Health
Cumberlege
Parliamentary Under-Secretary of State,
Department of Health
7th February 1995
Hector Monro
Parliamentary Under-Secretary of State, Scottish Office
7th February 1995
Signed by authority of the Secretary of State for Wales
Rod Richards
Parliamentary Under-Secretary of State, Welsh Office
15th February 1995
Regulation 2(f)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions |
| 8A. | 10750 | 002495-35-4 | Acrylic acid, benzyl ester | |
| 17A. | 11890 | 002499-59-4 | Acrylic acid, n-octyl ester | |
| 66A. | 15095 | 000334-48-5 | Decanoic acid | |
| 70A. | 15565 | 000106-46-7 | 1, 4-Dichlorobenzene | The specific migration of this substance shall not exceed 12 mg/kg. |
| 72A. | 15790 | 000111-40-0 | Diethylenetriamine | The specific migration of this substance shall not exceed 5 mg/kg. |
| 72B. | 15820 | 000345-92-6 | 4, 4' Difluorobenzophenone | The specific migration of this substance shall not exceed 0.05 mg/kg. |
| 91A. | 17160 | 000097-53-0 | Eugenol | The specific migration of this substance shall not exceed 0.01 mg/kg. |
| 110A. | 19210 | 001459-93-4 | Isophthalic acid, dimethyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg. |
| 116A. | 20080 | 002495-37-6 | Methacrylic acid, benzyl ester | |
| 124A. | 21280 | 002177-70-0 | Methacrylic acid, phenyl ester | |
| 131A. | 22390 | 000840-65-3 | 2, 6-Naphthalenedicarboxylic acid, dimethyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg. |
| 162A. | 24057 | 000089-32-7 | Pyromellitic anhydride | The specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid). |
| 172A. | 24475 | 001313-82-2 | Sodium sulphide | |
| 174A. | 24540 | 009005-25-8 | Starch, edible | |
| 180A. | 24888 | 003965-55-7 | 5-Sulphoisophthalic acid, monosodium salt, dimethyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg. |
| 181A. | 24940 | 000100-20-9 | Terephthalic acid dichloride | The specific migration of this substance shall not exceed 7.5 mg/kg (expressed as total of moiety or a terephthalic acid). |
| 183A. | 25120 | 000116-14-3 | Tetrafluoroethylene | The specific migration of this substance shall not exceed 0.05 mg/kg. |
Regulation 2(h)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions |
| 1. | As item 62 | 000542-02-9 | Acetoguanamine | |
| 2. | 10160 | 002206-94-2 | alpha-Acetoxystyrene | |
| 3. | 10162 | 010521-96-7 | beta-Acetoxystyrene | |
| 4. | 10480 | Acids, aliphatic, monocarboxylic, saturated (C2-C24) | ||
| 5. | 10510 | Acids, aliphatic, monocarboxylic, unsaturated (C3-C24) | ||
| 6. | 10599/70 | Acids, fatty, unsaturated (C18) | ||
| 7. | 10599/90A | 061788-89-4 | Acids, fatty, unsaturated (C18), dimers, distilled | |
| 8. | 10599/91 | 061788-89-4 | Acids, fatty, unsaturated (C18), dimers, non-distilled | |
| 9. | 10599/92A | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled | |
| 10. | 10599/93 | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled | |
| 11. | 10660 | 015214-89-8 | Acrylamidomethyl-propanesulphonic acid | |
| 12. | 10930 | 003066-71-5 | Acrylic acid, cyclohexyl ester | |
| 13. | 11000 | 050976-02-8 | Acrylic acid, dicyclo-pentadienyl ester | |
| 14. | 11050 | 001070-70-8 | Acrylic acid, diester with butan-1,4-diol | |
| 15. | 11180 | 017831-71-9 | Acrylic acid, diester with tetraethyleneglycol | |
| 16. | 11195 | 068901-05-3 | Acrylic acid, diester with tripropyleneglycol | |
| 17. | 11245 | 002156-97-0 | Acrylic acid, dodecyl ester | |
| 18. | 11500 | 000103-11-7 | Acrylic acid, 2-ethylhexyl ester | |
| 19. | 11520 | 002918-23-2 | Acrylic acid, 2-hydroxy-isopropyl ester (=acrylic acid, 2-hydroxy-1-methyl-ethyl ester) | |
| 20. | 11530 | 000999-61-1 | Acrylic acid, 2-hydroxy-propyl ester | |
| 21. | 11560 | 005888-33-5 | Acrylic acid, isobornyl ester | |
| 22. | 11620 | 001330-61-6 | Acrylic acid, isodecyl ester | |
| 23. | 11650 | 029590-42-9 | Acrylic acid, isooctyl ester | |
| 24. | 11695 | 003121-61-7 | Acrylic acid, 2-methoxy-ethyl ester | |
| 25. | 11740 | 010095-13-3 | Acrylic acid, monoester with butan-1,3-diol | |
| 26. | 11770 | 002478-10-6 | Acrylic acid, monoester with butan-1,4-diol | |
| 27. | 11800 | 013533-05-6 | Acrylic acid, monoester with diethyleneglycol | |
| 28. | 12010 | 040074-09-7 | Acrylic acid, 2-sulphoethyl ester | |
| 29. | 12040 | 039121-78-3 | Acrylic acid, sulphopropyl ester | |
| 30. | 12055 | 094160-26-6 | Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether | |
| 31. | 12062 | 075577-70-7 | Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether | |
| 32. | 12160 | 002998-04-1 | Adipic acid, diallyl ester | |
| 33. | 12190 | 000105-97-5 | Adipic acid, didecyl ester | |
| 34. | 12220 | 027178-16-1 | Adipic acid, diisodecyl ester | |
| 35. | 12250 | 000123-79-5 | Adipic acid, dioctyl ester | |
| 36. | 12265 | 004074-90-2 | Adipic acid, divinyl ester | |
| 37. | 12370 | Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22) | ||
| 38. | 12610 | 000107-18-6 | Allyl alcohol | |
| 39. | 12700 | 000150-13-0 | p-Aminobenzoic acid | |
| 40. | 12790 | 000080-46-6 | P-tert.-Amylphenol | |
| 41. | 12850 | 029602-44-6 | Azelaic acid, bis(2-hydroxyethyl) ester | |
| 42. | 12910 | 001732-10-1 | Azelaic acid, dimethyl ester | |
| 43. | As item 155 | 000528-44-9 | 1,2,4-Benzenetricarboxylic acid | |
| 44. | 13060 | 004422-95-1 | 1,3,5-Benzenetricarboxylic acid trichloride | As item 155 |
| 45. | As item 63 | 000091-76-9 | Benzoguanamine | |
| 46. | 13328 | 000104-38-1 | Bis(2-hydroxyethyl) ether of hydroquinone | |
| 47. | As item 71 | 000080-09-1 | Bisphenol S | |
| 48. | 13660 | 000584-03-2 | Butan-1,2-diol | |
| 49. | 13720 | 000110-63-4 | Butan-1,4-diol | |
| 50. | 13750 | 000513-85-9 | Butan-2,3-diol | |
| 51. | 13780 | 002425-79-8 | Butan-1,-diol bis(2,3-epoxypropyl) ether | The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 51 and 115 (and 16 and 20 of section D) shall not exceed 5 mg/kg (expressed as epoxy) |
| 52. | 13810 | 000505-65-7 | Butan-1,4-diol formal | |
| 53. | 13932 | 000598-32-3 | But-3-en-2-ol | |
| 54. | 13960 | 001852-16-0 | N-(Butoxymethyl)-acrylamide | |
| 55. | 14020 | 000098-54-4 | 4-tert.-Butylphenol | |
| 56. | 14260 | 000502-44-3 | Caprolactone | |
| 57. | As item 101, Section A | 000115-28-6 | Chlorendic acid | As item 101, Section A. |
| 58. | 14800 | 003724-65-0 | Crotonic acid | |
| 59. | 15020 | 002182-05-0 | Cyclohexyl vinyl ether | |
| 60. | 15070 | 001647-16-1 | Dec-1,9-diene | |
| 61. | 15130 | 000872-05-9 | Dec-1-ene | |
| 62. | 15280 | 000542-02-9 | 2,4-Diamino-6-methyl-1,3,5-triazine | |
| 63. | 15310 | 000091-76-9 | 2,4-Diamino-6-phenyl-1,3,5,-triazine | |
| 64. | 15340 | 000109-76-2 | 1,3-Diaminopropane | |
| 65. | 15370 | 003236-53-1 | 1,6-Diamino-2,2,4-trimethylhexane | |
| 66. | 15400 | 003236-54-2 | 1,6-Diamino-2,4,4-trimethylhexane | |
| 67. | 15490 | 002215-89-6 | 4,4'-Dicarboxydiphenyl ether | |
| 68. | 15580 | 001653-19-6 | 2,3-Dichlorobuta-1,3-diene | |
| 69. | 15610 | 000080-07-9 | 4,4'-Dichlorodiphenyl sulphone | |
| 70. | 15730 | 000077-73-6 | Dicyclopentadiene | |
| 71. | 16090 | 000080-09-1 | 4,4'-Dihydroxydiphenyl sulphone | |
| 72. | 16210 | 006864-37-5 | 3,3'-Dimethyl-4,4'-diamino-dicyclohexylmethane | |
| 73. | 16270 | 000526-75-0 | 2,3-Dimethylphenol | |
| 74. | 16300 | 000105-67-9 | 2,4-Dimethylphenol | |
| 75. | 16330 | 000095-87-4 | 2,5-Dimethylphenol | |
| 76. | 16360 | 000576-26-1 | 2,6-Dimethylphenol | |
| 77. | 16390 | 000126-30-7 | 2,2-Dimethylpropan-1,3-diol | |
| 78. | 16450 | 000646-06-0 | 1,3-Dioxolane | |
| 79. | 16540 | 000102-09-0 | Diphenyl carbonate | |
| 80. | 16690 | 001321-74-0 | Divinylbenzene | |
| 81. | 16697 | 000693-23-2 | Dodecanedioic acid | |
| 82. | 17040 | 000149-57-5 | 2-Ethylhexanoic acid | |
| 83. | 17050 | 000104-76-7 | 2-Ethylhexan-1-ol | |
| 84. | 17110 | 016219-75-3 | 5-Ethylidenebicyclo-[2.2.1]hept-2-ene | |
| 85. | 17350 | 000105-75-9 | Fumaric acid, dibutyl ester | |
| 86. | 18220 | 068564-88-5 | N-Heptylaminoundecanoic acid | |
| 87. | 18370 | 000592-45-0 | Hexa-1,4-diene | |
| 88. | 18400 | 000592-42-7 | Hexa-1,5-diene | |
| 89. | 18441 | 000085-42-7 | Hexahydrophthalic anhydride | |
| 90. | 18700 | 000629-11-8 | Hexan-1,6-diol | |
| 91. | 18820 | 000592-41-6 | Hex-1-ene | |
| 92. | 18905 | 002628-17-3 | 4-Hydroxystyrene | |
| 93. | 18970 | 000078-83-1 | Isobutanol | |
| 94. | 19030 | 016669-59-3 | N-(Isobutoxymethyl)-acrylamide | |
| 95. | 19060 | 000109-53-5 | Isobutyl vinyl ether | |
| 96. | 19090 | 000078-84-2 | Isobutyraldehyde | |
| 97. | 19120 | 025339-17-7 | Isodecanol | |
| 98. | 19130 | 026896-18-4 | Isononanoic acid | |
| 99. | 19150 | 000121-91-5 | Isophthalic acid | |
| 100. | 19180 | 000099-63-8 | Isophthalic acid dichloride | |
| 101. | As item 123 | 000078-79-5 | Isoprene | |
| 102. | 19270 | 000097-65-4 | Itaconic acid | |
| 103. | 19490 | 000947-04-6 | Laurolactam | |
| 104. | 19570 | 000999-21-3 | Maleic acid, diallyl ester | |
| 105. | 19600 | 000105-76-0 | Maleic acid, dibutyl ester | |
| 106. | 19936 | 007423-42-9 | Maleic acid, mono(2-ethylhexyl) ester | |
| 107. | 19990 | 000079-39-0 | Methacrylamide | |
| 108. | 20050 | 000096-05-9 | Methacrylic acid, allyl ester | |
| 109. | 20260 | 000101-43-9 | Methacrylic acid, cyclohexyl ester | |
| 110. | 20380 | 001189-08-8 | Methacrylic acid, diester with butan-1,3-diol | |
| 111. | 20410 | 002082-81-7 | Methacrylic acid, diester with butan-1,4-diol | |
| 112. | 20440 | 000097-90-5 | Methacrylic acid, diester with ethyleneglycol | |
| 113. | 20470 | 025852-47-5 | Methacrylic acid, diester with polyethyleneglycol | |
| 114. | 20530 | 002867-47-2 | Methacrylic acid, 2-(dimethylamino)-ethyl ester | |
| 115. | 20590 | 000106-91-2 | Methacrylic acid, 2,3-epoxypropyl ester | As item 51. |
| 116. | 20740 | 039670-09-2 | Methacrylic acid, ester with ethoxytriethyleneglycol | |
| 117. | 20950 | 000923-26-2 | Methacrylic acid, 2-hydroxypropyl ester | |
| 118. | 21115 | 000816-74-0 | Methacrylic acid, methallyl ester | |
| 119. | 21220 | 032360-05-7 | Methacrylic acid, octadecyl ester | |
| 120. | 21370 | 010595-80-9 | Methacrylic acid, 2-sulphoethyl ester | |
| 121. | 21400 | 054276-�35-�6 | Methacrylic acid, sulphopropyl ester | |
| 122. | 21520 | 001561-�92-�8 | Methallylsulphonic acid, sodium salt | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 123. | 21640 | 000078-�79-�5 | 2-Methylbut-1,3-diene | |
| 124. | 21730 | 000563-�45-�1 | 3-Methylbut-1-ene | |
| 125. | 21760 | 000694-�91-�7 | 5-Methylenebicyclo-[2.2.1]hept-2-ene | |
| 126. | As item 52 | 000505-�65-�7 | 1,4-(Methylene-dioxy)butane | |
| 127. | 21837 | 001116-�90-�1 | 4-methylhex-1,4-diene | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg). |
| 128. | 21970 | 000923-�02-�4 | N-Methylolmethacrylamide | |
| 129. | 22210 | 000098-�83-�9 | alpha-Methylstyrene | |
| 130. | 22240 | 000622-�97-�9 | p-Methylstyrene | |
| 131. | 22270 | 000107-�25-�5 | Methyl vinyl ether | |
| 132. | 22360 | 001141-�38-�4 | 2,6-Naphthalene-dicarboxylic acid | |
| 133. | As item 77 | 000126-�30-�7 | Neopentylglycol | |
| 134. | 22428 | 051000-�52-�3 | Neodecanoic acid, vinyl ester | |
| 135. | 22540 | 000104-�40-�5 | 4-Nonylphenol | |
| 136. | 13180 (also used for bicyclo [2.2.1] hept-2-ene) | 000498-�66-�8 | Norbornene | As item 39 on Part I Section C. |
| 137. | 22585 | 003710-�30-�3 | Octa-1,7-diene | |
| 138. | 22720 | 000140-�66-�9 | 4-tert.-Octylphenol | |
| 139. | 22900 | 000109-�67-�1 | Pent-1-ene | |
| 140. | 22932 | 001187-�93-�5 | Perfluoromethyl perfluorovinyl ether | |
| 141. | 22937 | 001623-�05-�8 | Perfluoropropyl perfluorovinyl ether | |
| 142. | 23530 | 025190-�06-�1 | Poly(1,4-butyleneglycol) (molecular weight greater than 1000) | |
| 143. | 23770 | 000504-�63-�2 | Propan-1,3-diol | |
| 144. | 23920 | 000105-�38-�4 | Propionic acid, vinyl ester | |
| 145. | 24370 | 000106-�79-�6 | Sebacic acid, dimethyl ester | |
| 146. | 24560 | 000111-�63-�7 | Stearic acid, vinyl ester | |
| 147. | 24760 | 026914-�43-�2 | Styrenesulphonic acid | |
| 148. | 25030 | 016646-�44-�9 | Tetra(allyloxy)ethane | |
| 149. | 25161 | 000085-�43-�8 | 1,2,3,6-Tetrahydrophthalic anhydride | |
| 150. | 25300 | 000088-�19-�7 | o-Toluenesulphonamide | |
| 151. | 25380 | Trialkyl(C5-C15) acetic acid, vinyl ester (=vinyl versatate) | ||
| 152. | 25390 | 000101-�37-�1 | Triallyl cyanurate | |
| 153. | 25450 | 026896-�48-�0 | Tricyclodecanedimethanol | |
| 154. | 25480 | 000102-�71-�6 | Triethanolamine | |
| 155. | 25540 | 000528-�44-�9 | Trimellitic acid | The quantity of this substance alone or together with item 156 in the finished plastic material or article shall not exceed 5 mg/kg. |
| 156. | 25550 | 000552-�30-�7 | Trimellitic anhydride | The quantity of this substance alone or together with item 155 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid). |
| 157. | 25810 | 015625-�89-�5 | 1,1,1-Trimethylolpropane triacrylate | |
| 158. | 25840 | 003290-�92-�4 | 1,1,1-Trimethylolpropane trimethacrylate | |
| 159. | 25900 | 000110-�88-�3 | Trioxane | |
| 160. | As item 154 | 000102-�71-�6 | Tris(2-hydroxyethyl)amine | |
| 161. | 26140 | 000075-38-7 | Vinylidene fluoride | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg). |
| 162. | 26170 | 003195-78-6 | N-Vinyl-N-methyl-acetamide | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 163. | 26230 | 000088-12-0 | Vinylpyrrolidone | |
| 164. | 26290 | 025013-15-4 | Vinyltoluene | |
| 165. | As item 130 | 000622-97-9 | p-Vinyltoluene | |
| 166. | 26320 | 002768-02-7 | Vinyltrimethoxysilane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 167. | As item 74 | 000105-67-9 | m-Xylenol | |
| 168. | As item 73 | 000526-75-0 | o-Xylenol | |
| 169. | As item 75 | 000095-87-4 | p-Xylenol |
Regulation 2(i)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions |
| 1. | 10599/90 | 061788-89-4 | Acids, fatty, unsaturated (C18), dimers | |
| 2. | 10599/92 | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated | |
| 3. | 10600 | Acids, linear, with an even number of carbon atoms (C8-C22), and the dimers and trimers of the unsaturated acids | ||
| 4. | 10720 | 000999-55-3 | Acrylic acid, allyl ester | |
| 5. | 10775 | 084100-23-2 | Acrylic acid, 4-tert. butylcyclohexyl ester | |
| 6. | 10990 | 002156-96-9 | Acrylic acid, decyl ester | |
| 7. | 11005 | 012542-30-2 | Acrylic acid, dicyclopentenyl ester | |
| 8. | 11010 | 024447-78-7 | Acrylic acid, diester with 2,2-bis (4-hydroxyphenyl)-propane bis (2-hydroxyethyl) ether | |
| 9. | 11020 | 019485-03-1 | Acrylic acid, diester with butan-1,3-diol | |
| 10. | 11080 | 004074-88-8 | Acrylic acid, diester with diethyleneglycol | |
| 11. | 11110 | 002274-11-5 | Acrylic acid, diester with ethyleneglycol | |
| 12. | 11140 | 013048-33-4 | Acrylic acid, diester with hexan-1,6-diol | |
| 13. | 11170 | 026570-48-9 | Acrylic acid, diester with polyethyleneglycol | |
| 14. | 11200 | 002426-54-2 | Acrylic acid, 2-(diethylamino) ethyl ester | |
| 15. | 11230 | 002439-35-2 | Acrylic acid, 2-(dimethylamino) ethyl ester | |
| 16. | 11260 | 000106-90-1 | Acrylic acid, 2,3-epoxypropyl ester | The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 16 and 20 (and 51 and 115 of Section B) shall not exceed 5 mg/kg (expressed as epoxy). |
| 17. | 11532 | 002761-08-2 | Acrylic acid, 3-hydroxypropyl ester | |
| 18. | 11860 | Acrylic acid, monoester with propyleneglycol | ||
| 19. | 11875 | 004813-57-4 | Acrylic acid, octadecyl ester | |
| 20. | 12640 | 000106-92-3 | Allyl 2,3-epoxypropyl ether | As item 16. |
| 21. | 13210 | 001761-71-3 | Bis (4-aminocyclohexyl) methane | |
| 22. | 14008 | 000098-52-2 | 4-tert.-Butylcyclohexanol | |
| 23. | 14035 | 001746-23-2 | 4-tert.-Butylstryrene | |
| 24. | 14560 | 000126-99-8 | 2-Chlorobutan-1,3-diene | |
| 25. | 14650 | 000079-38-9 | Chlorotrifluoroethylene | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 26. | 14833 | 000623-43-8 | Crotonic acid, methyl ester | |
| 27. | 14980 | 001631-25-0 | N-Cyclohexylmaleimide | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 28. | 15030 | 000931-88-4 | Cyclooctene | |
| 29. | 15060 | 000142-29-0 | Cyclopentene | |
| 30. | 15260 | 000646-25-3 | 1, 10-Diaminodecane | |
| 31. | 15270 | 002783-17-7 | 1, 12-Diaminododecane | |
| 32. | 15295 | 000373-44-4 | 1, 8-Diaminooctane | |
| 33. | 16120 | 000110-97-4 | Diisopropanolamine | |
| 34. | 16180 | 005205-93-6 | N-(Dimethylaminopropyl) methacrylamide | |
| 35. | 16252 | 000110-03-2 | 2, 5-Dimethylhexan-2, 5-diol | |
| 36. | 16510 | 000138-86-3 | Dipentene | |
| 37. | 16719 | 003813-52-3 | Endomethylene tetrahydrophthalic acid | |
| 38. | 16900 | 013036-41-4 | N- (Ethoxymethyl) − acrylamide | |
| 39. | 17116 | 005877-42-9 | 4-Ethyloct-l-yn-3-ol | |
| 40. | 17150 | 000078-27-3 | 1-Ethynylcyclohexanol | |
| 41. | 17305 | 000141-02-6 | Fumaric acid, bis (2-ethylhexyl ester) | |
| 42. | 17320 | 002807-54-7 | Fumaric acid, diallyl ester | |
| 43. | 17380 | 000623-91-6 | Fumaric acid, diethyl ester | |
| 44. | 17398 | 007283-68-3 | Fumaric acid, dioctadecyl ester | |
| 45. | 17800 | Glucosides obtained from glucose and pentaerythritol | ||
| 46. | 17830 | Glucosides obtained from glucose and polyethyleneglycol (molecular weight greater than 200) | ||
| 47. | 17860 | Glucosides obtained from glucose and polypropyleneglycol (molecular weight greater than 400) | ||
| 48. | 18436 | 001687-30-5 | Hexahydrophthalic acid | |
| 49. | 18490 | 015511-81-6 | Hexamethylenediamine adipate | |
| 50. | 18610 | 006422-99-7 | Hexamethylenediamine sebacate | |
| 51. | 18850 | 000107-41-5 | Hexyleneglycol | |
| 52. | 18865 | 003031-66-1 | Hex-3-yn-2,5-diol | |
| 53. | 19140 | 026952-21-6 | Isooctanol | |
| 54. | 19480 | 002146-71-6 | Lauric acid, vinyl ester | |
| 55. | 19660 | 000141-05-9 | Maleic acid, diethyl ester | |
| 56. | 19690 | 014234-82-3 | Maleic acid, diisobutyl ester | |
| 57. | 19720 | 001330-76-3 | Maleic acid, diisooctyl ester | |
| 58. | 19750 | 000624-48-6 | Maleic acid, dimethyl ester | |
| 59. | 19915 | 000925-21-3 | Maleic acid, monobutyl ester | |
| 60. | 20095 | 046729-07-1 | Methacrylic acid, 4-tert.-butylcyclohexyl ester | |
| 61. | 20200 | 001888-94-4 | Methacrylic acid, 2-chloroethyl ester | |
| 62. | 20320 | 003179-47-3 | Methacrylic acid, decyl ester | |
| 63. | 20455 | 006606-59-3 | Methacrylic acid, diester with hexan-1, 6-diol | |
| 64. | 20560 | 000142-90-5 | Methacrylic acid, dodecyl ester | |
| 65. | 20830 | Methacrylic acid, esters with propan-1, 2-diol | ||
| 66. | 20920 | 000688-84-6 | Methacrylic acid, 2- ethylhexyl ester | |
| 67. | 20945 | 004664-49-7 | Methacrylic acid, 2-hydroxyisopropyl ester (=methacrylic acid, 2-hydroxy-1-methylethyl ester) | |
| 68. | 20965 | 002761-09-3 | Methacrylic acid, 3-hydroxypropyl ester | |
| 69. | 20980 | 007534-94-3 | Methacrylic acid, isobornyl ester | |
| 70. | 21040 | 029964-84-9 | Methacrylic acid, isodecyl ester | |
| 71. | 21070 | 028675-80-1 | Methacrylic acid, isooctyl ester | |
| 72. | 21170 | 000997-46-6 | Methacrylic acid, monoester with butan-1, 4-diol | |
| 73. | 21250 | 002157-01-9 | Methacrylic acid, n-octyl ester | |
| 74. | 21430 | 004245-37-8 | Methacrylic acid, vinyl ester | |
| 75. | 21670 | 000563-46-2 | 2-Methylbut-l-ene | |
| 76. | 21733 | 000115-19-5 | 2-Methylbut-3-yn-2-ol | |
| 77. | 21736 | 002549-61-3 | alpha-Methyl-epsilon-caprolactone | |
| 78. | 21739 | 002549-60-2 | beta-Methyl-epsilon-caprolactone | |
| 79. | 21742 | 002549-58-8 | delta-Methyl-epsilon-caprolactone | |
| 80. | 21745 | 002549-59-9 | epsilon-Methyl-epsilon-caprolactone | |
| 81. | 21748 | 002549-42-0 | gamma-Methyl-epsilon-caprolactone | |
| 82. | 21850 | 000095-71-6 | Methylhydroquinone | |
| 83. | 21880 | 000717-27-1 | Methylhydroquinone diacetate | |
| 84. | 22465 | 000112-05-0 | Nonanoic acid | |
| 85. | 22690 | 001806-26-4 | 4-Octylphenol | |
| 86. | 22811 | 000591-93-5 | Pent-1, 4-diene | |
| 87. | 22842 | 002590-16-1 | Pentaerythritol diallyl ether | |
| 88. | 22858 | 005343-92-0 | Pentan-1, 2-diol | |
| 89. | 22861 | 000111-29-5 | Pentan-1, 5-diol | |
| 90. | 22901 | 000109-68-2 | Pent-2-ene | |
| 91. | 22935 | 003823-94-7 | Perfluoromethyl vinyl ether | |
| 92. | 22940 | 006996-01-0 | Perfluoropropyl vinyl ether | |
| 93. | 23140 | 000092-69-3 | 4-Phenylphenol | |
| 94. | 25158 | 000088-98-2 | 1, 2, 3, 6-Tetrahydrophthalic acid | |
| 95. | 25630 | 037275-47-1 | 1, 1, 1-Trimethylolpropane diacrylate | |
| 96. | 25645 | 000682-09-7 | 1, 1, 1-Trimethylolpropane diallyl ether | |
| 97. | 25780 | 025723-16-4 | 1, 1, 1-Trimethylolpropane propoxylated | |
| 98. | 25930 | 001067-53-4 | Tris (2-methoxyethoxy) vinylsilane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. |
| 99. | 26200 | 002867-48-3 | N-Vinyl-N-methylformamide | |
| 100. | 26260 | 001184-84-5 | Vinylsulphonic acid | " |
Regulation 2
| Conditions of contact in actual use | Test conditions |
|---|---|
| Contact time | Test time |
| t ≤ 0.5 hour | 0.5 hour |
| 0.5 hour < t ≤ 1 hour | 1 hour |
| 1 hour < t ≤ 2 hours | 2 hours |
| 2 hours < t ≤ 24 hours | 24 hours |
| t > 24 hours | 10 days |
| Contact temperature | Test temperature |
|---|---|
a Use simulant C at reflux temperature. | |
b Use simulant D at 150° or 175°C, in addition to simulants A, B and C used as appropriate at 100°C or at reflux temperature." | |
| T ≤ 5°C | 5°C |
| 5°C < T ≤ 20°C | 20°C |
| 20°C < T ≤ 40°C | 40°C |
| 40°C < T ≤ 70°C | 70°C |
| 7°C < T ≤ 100°C | 100°C or reflux temperature |
| 100°C < T ≤ 121°C | 121°Ca |
| 121°C < T ≤ 130°C | 130°Ca |
| 130°C < T ≤ 150°C | 150°Cb |
| T > 150°C | 175°Cb |
(This note is not part of the Regulations)
These Regulations amend the Plastic Materials and Articles in Contact with Food Regulations 1992 (S.I. 1992/3145) ("the principal Regulations") and implement Commission Directive 93/8/EEC (OJ No. L90, 14.4.93, p.22), amending Council Directive 82/711/EEC (OJ No. L297, 23.10.82, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, and Commission Directive 93/9/EEC (OJ No. L90, 14.4.93, p.26), amending Commission Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19, to be read with corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.
The Regulations-
provide that the capacity of an article specified in regulation 5(4)(b)(i) of the principal Regulations is less than 500 millilitres or more than 10 litres (regulation 2(a));
correct a drafting error in regulation 5(6) of the principal Regulations (regulation 2(b));
correct an error and an omission in the principal Regulations (regulation 2(c) and (d) respectively);
permit the use, sale or importation of plastic materials and articles manufactured using one or more of the monomers in Section D as inserted in Part I of Schedule 1 to the principal Regulations by these Regulations, until 1 April 1996 (regulation 2(e) and (i));
add specified monomers to those listed in Section A of Part I to Schedule 1 of the principal Regulations (monomers authorised without time limit) (regulation 2(f));
amend the restriction at item 26 (11- Aminoundecanoic acid) in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(g));
substitute for Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised to the end of 1996) an amended list with fewer authorised monomers (regulation 2(h));
add two further requirements to paragraph 4 of Section A of Part I of Schedule 2 to the principal Regulations specifying the conditions under which verification of compliance with migration limits is to be carried out using food and simulants respectively (regulation 2(j));
amend provisions relating to simulants to be used, and their use, in migration testing (regulation 2(k) and (l));
amend provisions relating to time and temperature test conditions (regulation 2(m) to (r));
amend the Food Safety (Sampling and Qualifications) Regulations 1990 (S. 1990/2463">1990/2463) so that those Regulations do not apply to any sample taken under the provisions of the principal Regulations (regulation 3).
A copy of the Compliance Cost Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and further copies can be obtained from the Chemical Safety of Food Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.
1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.
S.I. 1976/2141.
S.I. 1992/3145.
